MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number CR2

Device Problem Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

The customer has been provided with a replacement device.Stryker evaluated the customer's device and verified the reported issue.It was observed that the device was able to power on using the on/off button.Stryker determined that the cause of the reported issue was due to the lid switch, designator sw5.Stryker archived the device.

Event Description

The customer contacted stryker to report a non-critical issue with their device.Upon evaluation of the customer¿s device, stryker observed that the device would not power on when the device lid was activated.In this state defibrillation therapy may be delayed if needed or may lead to use error resulting in a failure to deliver defibrillation.There was no patient use associated with the reported event.

Manufacturer Narrative

Stryker evaluated the customer's device and verified the reported issue.It was observed that the device was able to power on using the on/off button.Stryker determined that the cause of the reported issue was due to the lid switch, designator sw5.Stryker archived the device.The customer received a replacement device.

Event Description

The customer contacted stryker to report a non-critical issue with their device.Upon evaluation of the customer¿s device, stryker observed that the device would not power on when the device lid was activated.In this state defibrillation therapy may be delayed if needed or may lead to use error resulting in a failure to deliver defibrillation.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) CR2 DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16250693
• MDR Text Key: 308260295
• Report Number: 0003015876-2023-00142
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873824085
• UDI-Public: 00883873824085
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 99512-001266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2022
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 03/19/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1